510(k) · Cleared
ClearedInfinity Gateway Suite, VF4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 21, 2005 as substantially equivalent to K030657 (Siemens Medical Solutions, 2003) after a 29-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 21, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900598 (1990). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 3 generations backK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
- 2 generations backK014213 Siemens Infinity Gateway SuiteSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK030657 Siemens Infinity Gateway Suite, Model VF2Siemens Medical Solutions · 2003
- This deviceK043549 Infinity Gateway Suite, VF4Draeger Medical Systems, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK203579 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK233834 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −3 | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −2 | K014213 | Siemens Infinity Gateway Suite | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K030657 | Siemens Infinity Gateway Suite, Model VF2 | Siemens Medical Solutions | 2003 | — |
| 0 (this device) | K043549 | Infinity Gateway Suite, VF4 | Draeger Medical Systems, Inc. | 2005 | — |
| +1 | K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022 | — |
| +2 | K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030657 | Siemens Infinity Gateway Suite, Model VF2Summary page 1…III 21 CFR 870.1025 Physiological Monitors Computers and Software, Medical LNX ~6~~~ O ME Legally Marketed Device Identification: K030657 INFINITY Gateway Suite Device Description: The Infinity Gateway Suite (K014213/K030657) is a server-based software application… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203579 | Infinity Gateway Suite | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K203579 (Draeger Medical Systems, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders.
The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043549: Infinity Gateway Suite, VF4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043549
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026